Associate Director/Director, Quality Assurance, CMC

Dianthus Therapeutics; United States; À distance; USD 180 000 - 240 000; Plein temps

Résumé du poste

Dianthus Therapeutics is seeking an Associate Director or Director of Quality Assurance (CMC) to lead QA oversight across development, manufacturing, and regulatory approval of our biologics. This remote role reports to the Executive Director, QA and partners with CMC, Manufacturing, Regulatory Affairs, and others to ensure quality and compliance.

You will oversee external CMOs/CTOs, drive deviations, change controls, risk assessments, and inspection readiness while guiding submissions

Qualifications

• BS or MS in Life sciences required.
• 10+ years in biotech/pharma with biologics.
• 5+ years QA oversight with CMOs.
• Strong knowledge of cGMP and ICH guidelines.

Responsabilités

• Provide QA oversight of CMO/CTO operations for biologics and combinations.
• Lead deviations, investigations, OOS results, and change controls.
• Support regulatory submissions (IND, BLA, IDE, PMA) and inspections.
• Collaborate with CMC Technical Operations, Manufacturing, Regulatory Affairs.
• Ensure EU release in collaboration with QP as needed.

Connaissances

QA oversight

cGMP compliance

Regulatory submissions

Quality systems

Deviations & CAPA

Root cause analysis

Batch disposition

Project management

Vendor management (CMOs)

Formation

Biology/ Chemistry/ Engineering degree

Outils

Veeva

Description du poste

Associate Director/Director, Quality Assurance, CMC

Remote

About Us

We are developing potentially best-in-class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections.Our newest candidate, DNTH312, is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. DNTH312 aims to be Phase 1 ready by year end 2027. To learn more, please visit www.dianthustx.com and follow us on LinkedIn .

About the Role

Dianthus Therapeutics is seeking an Associate Director or Director of Quality Assurance to join our growing CMC Quality team. In this role, you will provide quality oversight across the development, manufacturing, and regulatory approval of Dianthus products, with a direct impact on the investigational medicines we deliver to patients.

Reporting to the Executive Director, Quality Assurance, you will lead QA oversight of key external manufacturing (CROs) and testing partners (CTOs) across biologics and combination products. You will work closely with CMC Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, and other functions to solve complex quality challenges, support regulatory readiness, and ensure our clinical programs continue to move forward.

You will partner closely with CMC Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, and Project Management, working both independently and collaboratively to resolve issues and moving multiple complex programs forward in line with corporate goals and regulatory requirements.

We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

CMC and Manufacturing Oversight

• Provide QA oversight of CMO operations for cell banks, drug substance, and drug product/combination product, including review and approval of protocols, master batch records, starting material and finished product specifications, analytical test methods and raw data, stability reports, and method qualification/validation reports.
• Ensure clinical manufacturing operations comply with cGMP requirements and Dianthus policies and procedures.
• Disposition cell banks, drug substance, and finished drug product for clinical supply, including review of executed batch records and release and stability data.
• Work with our external Qualified Person (QP) to ensure investigational product is suitable for release in EU.
• Provide quality oversight of label and artwork review and approval.
• Provide quality input to process development, technology transfer, comparability, and stability strategies, and approve key technical protocols and reports.

Quality Systems and Compliance

• Serve as QA lead for deviations, investigations, OOS results, and change controls, including root-cause analysis and product impact assessment.
• Lead or participate in risk assessments, including design and process FMEAs.
• Partner with the Quality team to build, implement, and maintain phase-appropriate quality systems.
• Monitor the evolving regulatory landscape and update policies, procedures, specifications, and other quality documents accordingly.
• Act as the subject matter expert on CMC quality and compliance matters, providing guidance to teams across Dianthus.

External Partners, Audits, and Submissions

• Build and maintain strong quality relationships with CMOs, CTOs, and other strategic partners to support Dianthus’s expanding portfolio.
• Support GMP supplier audits and regulatory inspections.
• Support regulatory submissions (IND, BLA, IDE, PMA) and serve as QA lead for submission reviews.
• Perform other duties as assigned to support current program and business objectives.

Experience

• BS or MS in Biology, Chemistry, Engineering, or a related life sciences discipline.
• 10+ years of experience in the biotech or pharmaceutical industry with large molecules/biologics, including 5+ years in Quality Assurance oversight roles.
• 5+ years of experience developing, overseeing, and managing quality relationships with CMOs.
• 5+ years of experience performing batch disposition of GMP materials.
• Experience pharmaceutical manufacturing environment.
• Strong working knowledge of cGMPs and the drug development lifecycle, including 21 CFR Parts 210 and 211, 600s (for biologics), EU GMP (including Annex 1), and ICH Q8, Q9, and Q10.
• Experience with aseptic and sterile manufacturing principles.
• Strong knowledge of quality systems, including deviations, OOS, CAPA, change control, supplier management, and batch disposition.
• Experience authoring standard operating procedures.
• Experience reviewing analytical test results and associated raw data.
• Experience participating in formal, documented risk assessments (e.g., FMEA).
• Proven project management skills, with the ability to plan work, run effective meetings, and drive multiple projects to completion.
• Ability to understand business needs and translate them into practical, phase-appropriate (development, clinical) quality solutions.
• Excellent written and verbal communication skills, with the ability to build open, effective working relationships across the company.
• Results-oriented, decisive, and adaptable, with sound judgment and a proactive approach to identifying and resolving issues in a fast-growing company.

Preferred

• Combination product and/or medical device experience, including familiarity with 21 CFR Part 4 and 21 CFR Part 820 (QMSR)/ISO 13485.
• 2+ years of GxP auditing experience.
• Experience with electronic quality management systems (Veeva)